Cleared Traditional

K021174 - ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR

K021174 is an FDA 510(k) clearance for ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR, manufactured by Imagyn Surgical. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 382-day FDA review.

K021174 · Imagyn Surgical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
382d
Days
Class 2
Risk

K021174 is an FDA 510(k) clearance for the ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Imagyn Surgical (Richland, US). The FDA issued a Cleared decision on April 29, 2003 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Imagyn Surgical devices

FDA 510(k) Submission Details - K021174

510(k) Number K021174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received April 12, 2002
Decision Date April 29, 2003
Days to Decision 382 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
257d slower than avg
Panel avg: 125d · This submission: 382d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSB Device Classification - Class 2, Special Controls

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSB Plethysmograph, Impedance

All 17
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K021174.
Cardiovascular Analzyer
K172431 · Physiowave, Inc. · Mar 2018
ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
K131765 · Conmed Corporation · Dec 2013
C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
K041434 · Analogic Corp. · Aug 2004
ICG MODULE
K010164 · General Electric Medical Systems Information Techn · Apr 2001
PERCUPUMP II WITH EDA
K974621 · E-Z-Em, Inc. · Jan 1998
PERCUPUMP II WITH EDA
K961845 · E-Z-Em, Inc. · Jan 1997